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Eleventh Circuit Upholds Dismissal of Generic Reglan Suit

A Florida woman who claims that she was injured by Teva Pharmaceutical Industries Ltd.'s generic version of a brand-name drug manufactured by Wyeth LLC and Schwarz Pharma Inc. can't sue any of the companies, a U.S. Court of Appeals for the Eleventh Circuit panel ruled on Tuesday. The panel unanimously found that the woman's claims against Teva were barred by the U.S. Supreme Court's 2011 ruling in Pliva v. Mensing (which placed limits on suits against generic drug makers), and that her claims against Wyeth and Schwarz were barred by Florida state law.

The ruling added to what has already been a banner week for Teva counsel Jay Lefkowitz, the Kirkland & Ellis partner already known for winning Mensing. On Monday, Lefkowitz racked up another Supreme Court victory in Mutual Pharmaceutical Co. v. Bartlett.

Florida resident Andrea Guarino filed her suit in December 2010, claiming that she developed involuntary and repetitive body movements after taking Teva's generic version of Reglan, a gastrointestinal drug made by Wyeth and Schwarz. Guarino accused Teva of failing to reach out to doctors about the dangers of its generic version. She also claimed that Wyeth and Schwarz were liable because they too had an obligation to warn doctors and consumers. A U.S. district judge in Tampa dismissed Guarino's claims against Teva in November 2011, and granted summary judgment to Wyeth and Schwarz in April 2012.

Guarino and her lawyers—attorney David Sales and the law firm of Abrahamson & Uiterwyk, both based in Florida—appealed to the Eleventh Circuit in June 2012. They argued that Mensing didn't apply to their client's case. In Mensing, the Supreme Court ruled that all state failure-to-warn claims against generics are preempted by federal law, because generic drug companies are required under the Hatch-Waxman Act to have the same warning labels as their brand name counterparts. Guarino's lawyers maintained that generics like Teva still have an obligation to send letters to doctors warning them of dangerous side-effects of their drugs.

Teva's counsel countered that these so-called "dear doctor" letters are really an extension of the warning label, and generics could not send them to doctors unless their branded counterparts sent them first. In addition to Lefkowitz, Teva was represented by Goodwin Procter. Wyeth and Schwarz were represented by Bradley Arant Boult Cummings; Mayer Brown; and Williams & Connolly.

The Eleventh Circuit panel sided with Teva in its 18-page opinion, ruling that Guarino's case is controlled by Mensing. "Guarino's attempt to elude Mensing by clothing her allegations as 'failure-to-communicate' claims rather than failure-to-warn claims does not alter our analysis," Judge Charles Wilson wrote in the opinion, which was joined by judges Frank Hull and Jerome Farris.

The panel added that Wyeth and Schwarz were not liable in Guarino's case because she did not ingest their products. As such, they could not be sued under Florida law. "[N]o Florida court has recognized a potential cause of action against a branded manufacturer by the consumers of a generic product," wrote Wilson.

Lefkowitz told us that the ruling was clearly consistent with Mensing. "The Supreme Court said in Mensing that a generic company must fit into the [Food & Drug Administration's] labeling regime," Lefkowitz said. "Any communication about a drug from a generic company implies that there is some kind of difference with the branded drug, provided that the branded company did not send a letter, too." Lefkowitz added that forcing generics to send letters every time there was a change by the brand names was impractical. Kevin Newsom, who represented Wyeth and Schwarz, did not respond to a request for comment.

Sales, one of Guarino's lawyers, disagreed that Mensing forced generics to remain forever quiet. "Generics can only say what brand names secure the right to say, we obviously have to accept that," said Sales. "But this decision says they are not allowed to speak or communicate in any way even if it is to say something that is exactly identical to what's already on the label. That's unfortunate." Sales added that in his view, state law allows for branded companies to be sued even if a customer consumed the generic version of their product.